Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer (StoRM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01460186|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2011
Last Update Posted : February 28, 2018
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer.
1500 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study.
Patients will be treated and followed according to the standards of their treating center.
They will be followed during at least 5 years every 6 months for 3 years then every year.
|Condition or disease||Intervention/treatment|
|Breast Cancer Metastasis||Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)|
The StoRM trial is designed for analysis in association with the SIGNAL study which aims to decipher the genetic risk of breast cancer displaying amplification of the HER2 gene as well as resistance or toxicity to adjuvant treatments. SIGNAL study is in the process of recruiting 6000 localized breast cancer patients.
The purpose of the StoRM trial is to create a cohort of 1500 patients with metastatic breast cancer including detailed epidemiologic and treatment data. Using germ line polymorphisms in these patients and comparing them to patients with localized cancer from the SIGNAL study, the investigators will answer questions specific to the genetic influence on the prognosis of breast cancer and its response to treatments in the metastatic phase.
Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study. To simplify the evolution of the study and to avoid all confusion, the sample collection procedures followed will be identical to those used in the SIGNAL study.
As the samples are received at the biological resource center, the plasma will be aliquoted into a 500 µl tube and frozen at -80° C. DNA will be extracted using standard protocols. Plasma and DNA will be stored in anticipation of genetic analyses. An aliquot of the DNA sample will be genotyped for a panel of high-density genetic markers covering the whole genome, for genome-wide association studies.
The collected plasma may also be used for analyses to determine the expression profile of proteins, alone or combined with genetic factors that allow distinguishing between groups of patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Official Title:||Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study|
|Actual Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
|Experimental: Blood samples||
Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)
Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.
- Germ line genetic factors associated with metastatic relapse [ Time Frame: at the end of enrollment (2 years) ]Genetic determinants that predispose to a metastatic relapse of brest cancer by establishing germ line genetic variation based on single nucleotide polymorphisms of patients with metastatic breast cancer and comparing this variation to a cohort of patients with localized breast cancer (SIGNAL study)(correlation between polymorphisms and risk of relapse)
- Genetic determinants that predispose to specific metastatic localizations [ Time Frame: at the end of enrollment (2 years) ]Germ line polymorphisms will be analysed and tested for association with specific metastatic localizations as bone, lung, liver or central nervous system.
- Genetic determinants that predispose to metastatic relapse of specific molecular subtype of breast cancer [ Time Frame: at the end of enrollment (2 years) ]Germ line polymorphisms will be analysed and tested for association with metastatic relapse as a function of immunohistochemical/molecular characteristics of the primary tumor
- Overall survival [ Time Frame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up) ]Evaluate as a function of germ line polymorphisms overall survival after first-line treatment in metastatic setting
- Progression free survival [ Time Frame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up) ]Evaluate as a function of germ line polymorphisms progression free survival after first-line treatment in metastatic setting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460186
|Hôpital Jean Minjoz - CHU Besançon|
|BESANCON Cedex, France, 25030|
|Bordeaux, France, 33000|
|Centre François Baclesse|
|Caen, France, 14000|
|Centre Georges François Leclerc|
|DIJON Cedex, France, 21079|
|Institut Daniel Hollard|
|Grenoble, France, 38028|
|LIMOGES Cedex, France, 87042|
|Centre Léon Bérard|
|LYON Cedex 08, France, 69373|
|Institut Paoli Calmettes|
|Marseille, France, 13009|
|Montpellier, France, 34000|
|Centre Antoine Lacassagne|
|Nice, France, 06000|
|PARIS Cedex 05, France, 75248|
|Institut Jean Godinot|
|Reims, France, 51100|
|Centre René Gauducheau|
|SAINT HERBLAIN Cedex, France, 44805|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Institut Claudius Regaud|
|TOULOUSE Cedex, France, 31052|
|Centre Alexis Vautrin|
|Vandoeuvre les Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, 94805|
|Principal Investigator:||Thomas BACHELOT, MD||Centre Leon Berard|